A Phase 3, Single-Arm, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of Lomitapide in Japanese Patients With Homozygous Familial Hypercholesterolemia (HoFH) on Concurrent Lipid-Lowering Therapy

Trial Profile

A Phase 3, Single-Arm, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of Lomitapide in Japanese Patients With Homozygous Familial Hypercholesterolemia (HoFH) on Concurrent Lipid-Lowering Therapy

Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 28 Sep 2016

At a glance

  • Drugs Lomitapide (Primary)
  • Indications Hyperlipoproteinaemia type II
  • Focus Registrational; Therapeutic Use
  • Sponsors Aegerion Pharmaceuticals
  • Most Recent Events

    • 28 Sep 2016 According to Aegerion Pharmaceuticals media release, based upon the data of this trial, Japan's Ministry of Health, Labor & Welfare (MHLW) has approved JUXTAPID for patients with homozygous familial hypercholesterolemia (HoFH).
    • 11 Jan 2016 According to an Aegerion Pharmaceuticals media release, the company has submitted a New Drug Application to the Ministry of Health, Labour and Welfare (MHLW) for marketing approval of JUXTAPID for the treatment of homozygous familial hypercholesterolemia (HoFH) in Japan.
    • 17 Jun 2015 Planned End Date changed from 1 Jul 2015 to 1 Nov 2015 as reported by ClinicalTrials.gov record.
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